Long-term effectiveness and safety of ocrelizumab: a single-centre real-world study.

IF 4.8 2区医学 Q1 CLINICAL NEUROLOGY

Journal of Neurology Pub Date : 2025-06-28 DOI:10.1007/s00415-025-13224-8

Tiziana Zaccone, Lucia Moiola, Simone Guerrieri, Agostino Nozzolillo, Chiara Zanetta, Irene Gattuso, Angela Genchi, Federica Esposito, Maria G Scarale, Paola M V Rancoita, Maria A Rocca, Massimo Filippi

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引用次数: 0

Abstract

Background: This retrospective single-centre study evaluated the effectiveness and safety of ocrelizumab (OCR) in relapse-onset multiple sclerosis (RMS) and primary progressive MS (PPMS) and identified predictors of treatment response.

Methods: We included 260 RMS and 73 PPMS patients treated with ocrelizumab for ≥ 1 year at our MS Centre until May 2024.

Results: Median follow-up was 3.90 years for RMS and 4.23 years for PPMS. Within 2 years from treatment initiation, annualized relapse rate (ARR) decreased from 0.412 to 0.014 and was maintained low throughout follow-up in RMS, with no relapses in PPMS. MRI activity significantly declined and was maintained in both groups (p < 0.0001). After 3 years, confirmed disability progression (CDP)-free survival was high in relapsing-remitting MS (> 97%) and lower in secondary progressive MS (48.9%) and PPMS (57.2%). Predictors of ocrelizumab inefficacy included higher baseline Expanded Disability Status Scale (EDSS), older age and longer disease duration in RMS; male sex, older age and prior lower-efficacy treatments in PPMS. Adverse events were in line with previous clinical studies, with hypogammaglobulinemia and recurrent infections being the most frequent.

Conclusions: In this study we confirm ocrelizumab sustained efficacy in controlling inflammatory disease activity, with greater impact in RMS, with a favourable safety profile. Early treatment initiation is crucial to prevent irreversible disability accumulation.

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ocrelizumab的长期有效性和安全性：一项单中心现实世界研究

背景：这项回顾性单中心研究评估了ocrelizumab （OCR）治疗复发性多发性硬化症（RMS）和原发性进行性多发性硬化症（PPMS）的有效性和安全性，并确定了治疗反应的预测因素。方法：我们纳入了260名RMS和73名PPMS患者，在我们的MS中心接受ocrelizumab治疗≥1年，直到2024年5月。结果：RMS的中位随访时间为3.90年，PPMS的中位随访时间为4.23年。在治疗开始后的2年内，年化复发率（ARR）从0.412降至0.014，并在RMS随访期间保持较低水平，PPMS无复发。两组患者的MRI活动均显著下降并维持（p < 97%），继发性进展性MS患者的MRI活动下降（p < 48.9%）， PPMS患者的MRI活动下降（p < 57.2%）。ocrelizumab无效的预测因素包括基线扩展残疾状态量表（EDSS）较高、RMS中年龄较大和病程较长；男性，年龄较大，既往治疗效果较低。不良事件与先前的临床研究一致，低丙种球蛋白血症和复发性感染是最常见的。结论：在这项研究中，我们证实ocrelizumab在控制炎症疾病活动方面持续有效，对RMS有更大的影响，具有良好的安全性。早期治疗对于防止不可逆转的残疾积累至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Neurology 医学-临床神经学

CiteScore

10.00

自引率

5.00%

发文量

558

审稿时长

1 months

期刊介绍： The Journal of Neurology is an international peer-reviewed journal which provides a source for publishing original communications and reviews on clinical neurology covering the whole field. In addition, Letters to the Editors serve as a forum for clinical cases and the exchange of ideas which highlight important new findings. A section on Neurological progress serves to summarise the major findings in certain fields of neurology. Commentaries on new developments in clinical neuroscience, which may be commissioned or submitted, are published as editorials. Every neurologist interested in the current diagnosis and treatment of neurological disorders needs access to the information contained in this valuable journal.